![]() |
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
---|---|
Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00805077 |
The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy for lung cancer.
Condition | Intervention |
---|---|
Lung Neoplasms |
Procedure: mechanical ventilation Other: tidal volume |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pneumonectomy and Protective Mechanical Ventilation |
Estimated Enrollment: | 300 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | February 2012 |
Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
|
Procedure: mechanical ventilation
mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP
|
2
tidal volume of 10 ml/kg of ideal body weight without PEEP
|
Other: tidal volume
tidal volume of 10 ml/kg of ideal body weight without PEEP
|
Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE HOSPITAL, University of Paris-VI and by principal investigator.
Pneumonectomy is associated with a high risk for postoperative complication. The benefit of lung protective ventilation with low tidal volume has been demonstrated in patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent clinical studies have suggested that mechanical ventilation with low tidal volume may also profit in others setting. Lung protective ventilation during anaesthesia has been found to limit the inflammatory response in the lung and to decrease postoperative systemic inflammatory response. However, others trials did not found benefit of protective ventilation strategy during anaesthesia. This study will be a randomized, controlled, doubled blind trial comparing two management ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing pneumonectomy for lung primitive cancer will be included in this trial. During anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis, complications, cancer recurrence and death will be collected.
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Emmanuel Marret, MD | +33 (0) 1 56 01 65 72 | emmanuel.marret@tnn.aphp.fr |
France | |
Departement d'Anesthesie Reanimation, Hopital Tenon | Recruiting |
Paris, France, 75020 | |
Contact: Emmanuel Marret, MD 33 (0) 1 56 01 65 72 emmanuel.marret@tnn.aphp.fr | |
Principal Investigator: Emmanuel Marret, MD |
Principal Investigator: | Emmanuel Marret, MD | Hopital Tenon, Assistance Publique - Hopitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Mathieu Quintin ) |
Study ID Numbers: | P070119, A00821-52 |
Study First Received: | December 8, 2008 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00805077 History of Changes |
Health Authority: | France: Direction Générale de la Santé; France: French Data Protection Authority |
interoperative care Tidal volume Postoperative complications Pneumonectomy Mechanical ventilation |
Thoracic Neoplasms Respiratory Tract Diseases Postoperative Complications Lung Neoplasms Lung Diseases |
Thoracic Neoplasms Respiratory Tract Neoplasms Neoplasms Neoplasms by Site |
Respiratory Tract Diseases Lung Neoplasms Lung Diseases |